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RECRUITING
NCT04878094
PHASE3

A Study of Intra-operative Imaging in Women With Ovarian Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out whether using the PINPOINT imaging system intra-operatively can reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone. The PINPOINT endoscopic fluorescence imaging system uses a special camera and a fluorescent (glowing) dye that can evaluate the blood flow of the bowel in real-time. If there is an area that appears concerning, the surgeon can correct the problem during the procedure.

Official title: ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

310

Start Date

2021-05-03

Completion Date

2026-05-03

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Intravenous Indocyanine Green/ICG injection

Intravenous Indocyanine Green/ICG injection will be administered for visualization

DIAGNOSTIC_TEST

PINPOINT endoscopic fluorescence imaging system

After resection the surgeon will use the PINPOINT imaging system to assess perfusion of the colonic stump. The intervention will again be used following establishment of the anastomosis, however this time via a proctoscope to visualize the proximal and distal ends of the rectosigmoid anastomosis.

DIAGNOSTIC_TEST

Endoscopy

Standard technique and assessment of anastomosis without the use of NIR angiography

Locations (9)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Jefferson Abington Hospital

Willow Grove, Pennsylvania, United States

Houston Methodist Cancer Center (Data Collection Only)

Houston, Texas, United States